The Effects of Treadmill Versus Agility Training in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Kinetics Foundation
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00982709
First received: September 22, 2009
Last updated: June 24, 2011
Last verified: July 2010

September 22, 2009
June 24, 2011
January 2009
January 2011   (final data collection date for primary outcome measure)
Dynamic Posturography [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00982709 on ClinicalTrials.gov Archive Site
UPDRS [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]
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The Effects of Treadmill Versus Agility Training in Parkinson's Disease
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Aim:

To determine the Responsiveness of the iMOBILITY in response to intensive physical therapy exercise programs. (Is it sensitive to change?) Although exercise is thought to be the most effective intervention for balance and gait in PD (compared to dopaminergic medication or DBS surgery), the best exercise program for mobility in PD is unknown. The iMOBILITY will be used to quantify balance and gait performance before and after two PT-supervised, intensive, exercise programs, expected to improve balance and gait. The first program is a published Treadmill training program and the second is the investigators new Agility training program with sensorimotor progressions, targeted at specific impairments that underlie the abnormalities of balance and gait in PD (developed for the Kinetics Foundation). This pilot clinical trial will randomize 40 PD subjects into the two exercise programs at OHSU in preparation for a larger clinical trial to determine the most effective exercise for mobility disability in PD. The effects of exercise will be compared with no treatment during a 5-week delay prior to start of exercise.

This trial will also determine the relative responsiveness (compared to traditional clinical scales) of the iMOBILITY for testing the hypothesis that intensive exercise can improve mobility in PD. We will use existing instruments (Berg Balance Scale, BEST of dynamic balance, UPDRS, PDQ-39, 5 times sit-to-stand time and the Functional Performance Battery) to show there is a difference between the exercise groups. Superior responsiveness of the iMOBILITY system will be determined by larger differences with exercise intervention with the iMOBILITY system than with traditional clinical measures of mobility in PD.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Exercise
  • Parkinson's Disease
Behavioral: Aerobic vs. Agility Training
High Intensity 4x's per week for 4 weeks with a physical therapist.
Other Name: agility, treadmill
Active Comparator: Exercise Types
comparing two different exercise programs for PD
Intervention: Behavioral: Aerobic vs. Agility Training
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Idiopathic PD

Exclusion Criteria:

  • Other neurological conditions, artificial joints
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00982709
4402
No
Fay Horak, OHSU
Oregon Health and Science University
Kinetics Foundation
Not Provided
Oregon Health and Science University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP